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- Faculty Publications (32)
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- All HBS Web (135)
- Faculty Publications (32)
- 23 Apr 2014
- HBS Case
Are Electronic Cigarettes a Public Good or Health Hazard?
make "vapes" attractive to children. Some states and cities responded with restrictions on sales and advertising, and, in April, the Financial Times reported that the World Health Organization will call for e-cigarettes to be View Details
- 04 Sep 2018
- First Look
New Research and Ideas, September 4, 2018
It subsequently became much more arduous for pharmaceutical firms to bring new drugs to market. Some critics therefore argued that the new regulations were actually detrimental, as they prevented or delayed... View Details
Keywords: Dina Gerdeman
- 11 Jan 2017
- Research & Ideas
The Paradoxical Quest to Make Food Look 'Natural' With Artificial Dyes
chromate was used to make milk look creamier; and various poisonous ingredients were used to create bright colors for various candies, reportedly causing some children to fall ill or even die. Hisano highlights key dates in food coloring View Details
Keywords: by Carmen Nobel
- 24 Sep 2007
- Research & Ideas
The FDA: What Will the Next 100 Years Bring?
The U.S. Food and Drug Administration, which was created by the passage of the 1906 Federal Food and Drugs Act, regulates companies and industries accounting for one-quarter of... View Details
- 12 Jul 2016
- First Look
July 12, 2016
Case 816-005, "Bigbelly," by Mitchell Weiss and Christine Snively. This case is an example of public entrepreneurship. Publisher's link: https://www.hbs.edu/faculty/Pages/item.aspx?num=51306 Financial Regulation in a Quantitative Model of... View Details
Keywords: Sean Silverthorne
- Teaching Interest
Overview
By: Leemore S. Dafny
U.S. Healthcare Strategy
The U.S. healthcare sector accounts for 17 percent of GDP, and encompasses a diverse set of industries with public, nonprofit, and for-profit buyers and sellers. There are significant concerns about high and rising spending, and... View Details
- November 2022
- Case
The Battle Among Channels for Marketing Pharmaceuticals: UpScript, Pharmacy Benefit Managers, and Direct-to-Consumer Sales
By: Regina E. Herzlinger and Tiffany Farrell
Can an online, direct-to-consumer pharmacy both improve the quality and speed of care for patients who need branded drugs and stabilize profits for pharmaceutical manufacturers? UpScript, after years spent achieving legal and regulatory compliance and simultaneous... View Details
Keywords: DTC; Internet and the Web; Marketing Channels; Customer Value and Value Chain; Governing Rules, Regulations, and Reforms; Competitive Strategy; Service Delivery; Growth and Development Strategy; Pharmaceutical Industry; Health Industry; Retail Industry
Herzlinger, Regina E., and Tiffany Farrell. "The Battle Among Channels for Marketing Pharmaceuticals: UpScript, Pharmacy Benefit Managers, and Direct-to-Consumer Sales." Harvard Business School Case 323-031, November 2022.
- 19 Dec 2017
- First Look
New Research and Ideas, December 19, 2017
Abstract—No abstract available. Publisher's link: https://www.hbs.edu/faculty/Pages/item.aspx?num=53633 Characterizing the Drug Development Pipeline for Precision Medicines By: Chandra, Amitabh, Craig Garthwaite, and Ariel Dora Stern... View Details
Keywords: Carmen Nobel
- 15 Jan 2019
- First Look
New Research and Ideas, January 15, 2019
December 19, 2018 NEJM Catalyst It's Time to Reform the Orphan Drug Act By: Bagley, Nicholas, Amitabh Chandra, Craig Garthwaite, and Ariel Dora Stern Abstract—No abstract available. Publisher's link:... View Details
Keywords: Dina Gerdeman
- Web
Capstone | MBA
centuries of de-prioritization. For example, regulations barred women of reproductive age from clinical trials until the 1990s. Organoid systems, which recreate human physiology, make it possible to conduct scientific investigation far... View Details
- 21 Aug 2007
- First Look
First Look: August 21, 2007
http://www.hbsp.harvard.edu/b01/en/common/item_detail.jhtml?id=807074 PublicationsPerspectives on Risk and Regulation: The FDA at 100 Author:Arthur A. Daemmrich Publication:Chemical Heritage Press, 2007 Abstract Perspectives on Risk and Regulation: The FDA at 100... View Details
Keywords: Martha Lagace
- 02 Sep 2008
- First Look
First Look: September 3, 2008
spillover effects. In the domain of private politics, shareholder resolutions filed against a firm, and against others in its industry, increase its propensity to acquiesce to these shareholder requests. Similarly, in the realm of public politics, the threat of state... View Details
Keywords: Sean Silverthorne
- 10 Oct 2007
- First Look
First Look: First Look: October 10
corporate confessions presents something of a behavioral paradox. Tasked with monitoring the legality of its own operations, why would firms that identify violations turn themselves in to regulators rather than quietly fix the problem?... View Details
Keywords: Martha Lagace
- 23 Sep 2008
- First Look
First Look: September 23, 2008
presided over the development of the empirical social sciences to address questions of labor regulation and control within manufacturing industries. Next, we look at the creation of the Carnegie Tech Graduate School of Industrial... View Details
Keywords: Martha Lagace
- Web
Curriculum - Case Method Project
explosive but unorthodox piece of investigative journalism presented in the form of a novel, almost overnight transformed the political environment surrounding federal regulation of the powerful meat-packing industry. Coverage: 1850 –... View Details
- Web
Great American Business Leaders of the 20th Century - Leadership
William H. Danforth Ralston Purina Company, 1894–1932 Justin Dart United Drug Company, 1943–1980 Francis B. Davis Jr. United States Rubber Company, 1929–1942 Arthur V. Davis Alcoa, 1910–1928 Charles S. Davis Borg-Warner Corporation,... View Details
- 28 Apr 2009
- First Look
First Look: April 28, 2009
consumer-oriented model for drug development and use has attracted attention in recent years as an alternative to the much-maligned approach of mass-marketing blockbuster drugs. In a parallel development, patients and disease-based... View Details
Keywords: Martha Lagace
- 20 Nov 2007
- First Look
First Look: November 20, 2007
discipline to nationalized banks. Pharmaceutical Regulation in the United States and Europe Author:Arthur Daemmrich Periodical:Focus on Law Studies 23, no 1 (fall 2007): 8-11 Read the full paper:... View Details
Keywords: Martha Lagace
- 2023
- Article
Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
Importance: Most regulated medical devices enter the U.S. market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are “substantially equivalent” to 1 or more “predicate” devices (legally marketed medical devices... View Details
Everhart, Alexander O., Soumya Sen, Ariel D. Stern, Yi Zhu, and Pinar Karaca-Mandic. "Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 2 (2023): 144–156.
- 02 Mar 2007
- What Do You Think?
What Is the Government’s Role in US Health Care?
Newman), the high cost of new technology, artificial restrictions on the supply of drugs (Sergey Mirkiin) and healthcare providers (David Stahl and Michael Robbins), the size and complexity of the problem itself (James Sullivan),... View Details